Binatta

PACKAGE LEAFLET

Package leaflet: information for the patient

BINATTA, 25 mg, prolonged-release tablets
BINATTA, 50 mg, prolonged-release tablets
BINATTA, 100 mg, prolonged-release tablets
BINATTA, 150 mg, prolonged-release tablets
BINATTA, 200 mg, prolonged-release tablets
BINATTA, 250 mg, prolonged-release tablets
Tapentadol
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What BINATTA is and what it is used for
2. What you need to know before taking BINATTA
3. How to take BINATTA
4. Possible side effects
5. How to store BINATTA
6. Contents of the pack and other information

1. What BINATTA is and what it is used for

Tapentadol, the active substance in BINATTA, is a potent analgesic belonging to the opioid group. BINATTA is indicated for the management of severe chronic pain in adults, when treatment with an opioid analgesic is required for an extended period.

2. Important information before using the medicine BINATTA

When not to use BINATTA:

• if the patient is allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• in patients with asthma or dangerously slow and shallow breathing (respiratory depression, increased carbon dioxide levels in the blood),
• in patients with intestinal obstruction,
• in case of acute alcohol, hypnotic, analgesic or other psychotropic drug intoxication (drugs affecting mood and emotions) (see "BINATTA with other medicines").

Warnings and precautions
Before starting treatment with BINATTA, discuss the following with your doctor or pharmacist:

• if the patient has slow or shallow breathing,
• if the patient has increased intracranial pressure or impaired consciousness up to coma,
• in patients after head injury or with brain tumors,
• in patients with liver or kidney disease (see "How to use BINATTA"),
• in patients with diseases of the pancreas or biliary tract, including pancreatitis,
• in patients taking drugs with mixed agonist/antagonist properties at opioid "mu" receptors (e.g. pentazocine, nalbuphine) or drugs that are partial agonists of the opioid "mu" receptor (e.g. buprenorphine),
• in patients with a history of seizures or convulsions, or when taking other medicines that increase the risk of seizures and may increase seizure risk,
• if there is a family history of alcohol, drug or substance abuse or addiction ("addiction"),
• in patients who smoke tobacco,
• in patients who have ever had mood problems (depression, anxiety disorders or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid analgesics may lead to reduced effectiveness of the medicine (tolerance). It may also lead to dependence and abuse, which could result in life-threatening overdose. If you are concerned about becoming addicted to BINATTA, consult your doctor. Use of the medicine (even at therapeutic doses) may lead to physical dependence, which may result in withdrawal symptoms and recurrence of problems if treatment is stopped abruptly.
BINATTA may cause physical and psychological dependence. In patients with a tendency to drug abuse or history of addiction, treatment should be short-term and carried out under strict medical supervision.

Sleep-related breathing disorders
BINATTA may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (reduced oxygen levels in the blood during sleep). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep continuity, or excessive daytime sleepiness. If these symptoms occur, contact your doctor. The doctor may consider reducing the dose of the medicine.

BINATTA with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• The risk of adverse effects increases if the patient takes medicines that may cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of seizures may increase if the patient is also taking BINATTA. Your doctor will inform you whether BINATTA is suitable for you.

• Concomitant use of BINATTA and sedative medicines such as benzodiazepines or related drugs (some sleeping tablets or sedatives, e.g. barbiturates), or analgesics such as opioids, morphine and codeine (also as a cough medicine), antipsychotics, H1 antihistamines, or alcohol increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of such medicines should only be considered when other treatment options are not possible. If your doctor prescribes BINATTA together with sedative medicines, the dose and duration of concomitant treatment should be minimized. Concomitant use of opioids and medicines used to treat epilepsy, neuropathic pain or anxiety disorders (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be life-threatening. Inform your doctor if you are taking gabapentin, pregabalin or sedative medicines and strictly follow his or her instructions. It is advisable to inform family members or close contacts about the possibility of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor immediately.

• If the patient is taking medicines that affect serotonin levels (e.g. certain medicines used to treat depression), he or she should consult a doctor before taking BINATTA due to the possibility of developing "serotonin syndrome." Serotonin syndrome is rare but may be life-threatening. Symptoms include uncontrolled, rhythmic muscle contractions, including those affecting eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide appropriate information on this matter.

• Concomitant use of BINATTA with opioid medicines belonging to mixed mu-receptor agonist/antagonists (e.g. pentazocine, nalbuphine) or partial mu-receptor agonists (e.g. buprenorphine) has not been studied. It is possible that BINATTA may not work properly if used simultaneously with medicines from the above-mentioned groups. Inform your doctor immediately if you are currently taking any of the medicines listed above.

• Concomitant use of BINATTA with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's wort) of certain enzymes required for tapentadol elimination from the body may affect tapentadol's action or may cause adverse effects, especially when starting or stopping these medicines. Inform your doctor about all medicines currently being taken.

• BINATTA should not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been used within the last 14 days.

BINATTA with food, drink and alcohol
Do not drink alcohol while taking BINATTA, as certain adverse effects such as drowsiness may be intensified. The medicine can be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Do not use BINATTA:

• during pregnancy unless the doctor decides it is necessary. Prolonged use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not recognized and treated by a doctor;
• during breastfeeding, as the medicine may be excreted in breast milk.

Use of BINATTA is not recommended:

• during childbirth, as it may cause dangerous slowing or depression of the newborn's breathing (respiratory depression).

Driving and operating machinery
BINATTA may cause drowsiness, dizziness, blurred vision and affect reaction ability. These symptoms may occur especially at the beginning of treatment with BINATTA, after a dose adjustment recommended by the doctor, or when alcohol or sedative medicines are used concomitantly. Ask your doctor whether driving and operating machinery are permitted after taking the medicine.

3. How to use BINATTA

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of pain and individual patient sensitivity to pain.
In general, the lowest effective dose for pain relief should be used.
Adults
The usual initial dose is 50 mg, administered twice daily, approximately every 12 hours.
Total daily doses of BINATTA exceeding 500 mg of tapentadol are not recommended.
Your doctor may recommend a different, more appropriate dosage or interval between doses if necessary. If you feel that the effect of the medicine is too strong or too weak, you should contact your doctor or pharmacist.
Elderly patients
Dosage adjustment is usually not required in elderly patients (over 65 years of age). However, elimination of tapentadol may be prolonged in patients in this age group, and therefore your doctor may recommend a different dosing regimen.
Patients with impaired liver or kidney function
Patients with severe liver dysfunction should not use this medicine. In cases of moderate liver dysfunction, your doctor will recommend an adjusted dosing regimen. Patients with mild liver dysfunction do not require dose adjustment.
Patients with severe kidney dysfunction should not use this medicine. Dose adjustment is not required in patients with mild or moderate kidney dysfunction.
Use in children and adolescents
BINATTA is not recommended for use in children and adolescents under 18 years of age.
Method of administration of BINATTA
BINATTA tablets should be taken orally.
The tablet should be swallowed whole with sufficient fluid. Tablets must not be chewed or crushed,

• as this may lead to overdose due to too rapid release of the medicine in the body. The medicine can be taken on an empty stomach or with food.

The tablet may be divided into equal doses.
The empty tablet shell may not be completely digested and may appear in the stool. This is not a cause for concern, as the medicine (active substance) has already been absorbed by the body, and only the tablet shell remains in the stool.
Instructions for opening the blister pack
This medicine is supplied in child-resistant, perforated blister packs, divided into single doses. Tablets cannot be pushed through the blister. The blister packs should be opened according to the following instructions:

1. Tear off a single dose along the perforated line of the blister.

2. At the intersection of the lines there is an unprotected area.

3. Pull the unprotected part to remove the upper protective layer.

Duration of treatment with BINATTA
Do not use the tablets for longer than recommended by your doctor.
Taking more than the recommended dose of BINATTA
After taking very large doses, the following symptoms may occur:

• pinpoint constriction of the pupils,
• vomiting,
• drop in arterial blood pressure,
• rapid heartbeat,
• collapse, disturbances of consciousness or coma (deep unconscious state),
• seizures,
• dangerously slow or shallow breathing or respiratory arrest. In such cases, seek immediate medical attention!

Missed dose of BINATTA
If a patient forgets to take the medicine, pain symptoms will likely return. Do not take a double dose to make up for the missed dose. Resume the usual dosing schedule.
Stopping treatment with BINATTA
If treatment is interrupted or discontinued before completion, pain symptoms are likely to return. You should contact your doctor before stopping the medicine.
Generally, no adverse effects are observed after discontinuation of the medicine; however, in rare cases, patients who have been taking the medicine for some time and stop it abruptly may experience general malaise.
The following symptoms may occur:

• restlessness, lacrimation, runny nose, yawning, sweating, chills, muscle pain, and pupil dilation,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhoea, increased arterial blood pressure, respiratory rate, and heart rate. If any of the above symptoms occur after stopping treatment, consult your doctor immediately. Do not stop taking the medicine suddenly, unless your doctor advises you to do so. Your doctor will inform you how to discontinue the medicine. Discontinuation may involve gradually reducing the dose.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Important adverse reactions or symptoms to watch for, and what to do if they occur:

• This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, particularly affecting the whole body.
• Another serious adverse reaction is excessive slowing and shallowing of breathing. This most commonly occurs in elderly and weakened patients.

If any of these important adverse reactions affect the patient, contact a doctor immediately.
Other adverse reactions that may occur:
Very common (may affect more than 1 in 10 people)

• nausea, constipation,
• dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people)

• loss of appetite, anxiety, depressed mood, sleep disturbances, restlessness, motor agitation, difficulty concentrating,
• tremor, muscle cramps,
• flushing,
• shortness of breath,
• vomiting, diarrhoea, dyspepsia,
• itching, excessive sweating, rash,
• feeling weak, fatigue, sensation of body temperature change, dryness of mucous membranes, fluid retention (oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, low blood pressure, collapse or shock),
• weight loss,
• disorientation, confusion, agitation, perceptual disturbances, unusual dreams, euphoric mood, reduced level of consciousness, impaired memory, psychiatric disorders,
• fainting, excessive sedation, balance disorders, speech disorders, numbness, abnormal skin sensations (e.g. tingling, pricking),
• visual disturbances,
• faster heartbeat, slower heartbeat, palpitations, reduced arterial pressure,
• abdominal discomfort,
• urticaria,
• difficulty passing urine, frequent urination,
• sexual dysfunction,
• withdrawal syndrome (see "Stopping treatment with BINATTA"), feeling of abnormality, irritability.

Rare (may affect up to 1 in 1000 people)

• drug dependence, thinking disorders, seizures, feeling of impending fainting, coordination disorders,
• dangerously slow or shallow breathing (respiratory depression),
• impaired gastric emptying,
• sensation of alcohol intoxication, feeling of relaxation.

Frequency not known (cannot be estimated from available data)

• hallucinations.

Generally, the likelihood of suicidal thoughts and behaviours is higher in patients with chronic pain. Additionally, medicines used to treat depression (which affect the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data obtained from its use in humans have not provided evidence of an increased risk.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine BINATTA

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine BINATTA contains

• The active substance is tapentadol.

BINATTA 25 mg, prolonged-release tablets
Each prolonged-release tablet contains 25 mg of tapentadol (as phosphate).
BINATTA 50 mg, prolonged-release tablets
Each prolonged-release tablet contains 50 mg of tapentadol (as phosphate).
BINATTA 100 mg, prolonged-release tablets
Each prolonged-release tablet contains 100 mg of tapentadol (as phosphate).
BINATTA 150 mg, prolonged-release tablets
Each prolonged-release tablet contains 150 mg of tapentadol (as phosphate).
BINATTA 200 mg, prolonged-release tablets
Each prolonged-release tablet contains 200 mg of tapentadol (as phosphate).
BINATTA 250 mg, prolonged-release tablets
Each prolonged-release tablet contains 250 mg of tapentadol (as phosphate).

• Other ingredients are:
  Tablet core: microcrystalline cellulose (E 460); hypromellose (E 464); colloidal anhydrous silica (E 551); magnesium stearate.
  Tablet coating: hypromellose (E 464); glycerol (E 422); talc (E 553b); microcrystalline cellulose (E 460); titanium dioxide (E 171); red iron oxide (E 172) (only for strengths 25, 100, 150, 200 and 250 mg); yellow iron oxide (E 172) (only for strengths 25, 100 and 200 mg); black iron oxide (E 172) (only for strengths 25, 100, 150, 200 and 250 mg).

What BINATTA looks like and contents of the pack
BINATTA 25 mg: brownish, prolonged-release, elongated, biconvex tablets (6 mm x 12 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 50 mg: white, prolonged-release, elongated, biconvex tablets (6 mm x 13 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 100 mg: yellowish, prolonged-release, elongated, biconvex tablets (7 mm x 14 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 150 mg: light red, prolonged-release, elongated, biconvex tablets (7 mm x 15 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 200 mg: yellow, prolonged-release, elongated, biconvex tablets (8 mm x 16 mm) with a score line on both sides.
The tablet can be divided into equal doses.
BINATTA 250 mg: reddish-brown, prolonged-release, elongated, biconvex tablets (9 mm x 18 mm) with a score line on both sides.
The tablet can be divided into equal doses.

BINATTA is available in packs containing:
BINATTA 25 mg
20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in single-dose, perforated blisters, child-resistant packaging.
BINATTA 50–250 mg
20x1, 24x1, 30x1, 50x1, 54x1, 60x1 or 100x1 prolonged-release tablets in single-dose, perforated blisters, child-resistant packaging.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
Develco Pharma GmbH
Grienmatt 27
Farhnau
79650 Schopfheim
Germany
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

For further information on this medicine, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Poland
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Tapentadol AL 25 mg Retardtabletten
Tapentadol AL 50 mg Retardtabletten
Tapentadol AL 100 mg Retardtabletten
Tapentadol AL 150 mg Retardtabletten
Tapentadol AL 200 mg Retardtabletten
Tapentadol AL 250 mg Retardtabletten
Croatia TAPISTA
Czech Republic Taxemba
Denmark Tapentadol STADA
Iceland Tapentadol STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; forðahylki
Italy Mudol
The Netherlands Tapentadol retard CF 25 mg, tabletten met verlengde afgifte
Tapentadol retard CF 50 mg, tabletten met verlengde afgifte
Tapentadol retard CF 100 mg, tabletten met verlengde afgifte
Tapentadol retard CF 150 mg, tabletten met verlengde afgifte
Tapentadol retard CF 200 mg, tabletten met verlengde afgifte
Tapentadol retard CF 250 mg, tabletten met verlengde afgifte
Norway Tapentadol STADA
Poland BINATTA
Slovakia Tapestad retard 50 mg, 100 mg, 150 mg, 200 mg, 250 mg
Spain Tapentadol retard STADA 25 mg comprimidos de liberación prolongada EFG
Tapentadol retard STADA 50 mg comprimidos de liberación prolongada EFG
Tapentadol retard STADA 100 mg comprimidos de liberación prolongada EFG
Tapentadol retard STADA 150 mg comprimidos de liberación prolongada EFG
Tapentadol retard STADA 200 mg comprimidos de liberación prolongada EFG
Tapentadol retard STADA 250 mg comprimidos de liberación prolongada EFG
Sweden Tapentadol Depot STADA 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg; depottabletter